Phase 3
Completed N=321
A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients
Source: ClinicalTrials.gov NCT01631825 ↗Enrolled (actual)
321
Serious AEs
10.6%
Results posted
Mar 2014
Primary outcomePrimary: Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters — 311; 269; 34; 6 participants
Summary
* To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study.
* To investigate efficacy of SPM 962 in an exploratory manner.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters |
311; 269; 34; 6; 16; 47 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score |
-8.3; -8.0; -7.5 | — |
| SECONDARY UPDRS Part 2 Sum Score (Average of on State and Off State) |
-2.6; -2.5; -1.9 | — |
| SECONDARY Absolute Time Spent "Off" |
-2.5; -2.5; -2.0 | — |
| SECONDARY UPDRS Part 1 Sum Score |
-0.33; -0.25; -0.15 | — |
| SECONDARY UPDRS Part 2 Sum Score (On State) |
-1.9; -1.7; -1.3 | — |
| SECONDARY UPDRS Part 2 Sum Score (Off State) |
-3.7; -3.8; -2.5 | — |
| SECONDARY UPDRS Part 4 Sum Score |
-0.24; -0.28; -0.13 | — |
| SECONDARY Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score |
-11.4; -11.1; -9.7 | — |
| SECONDARY The Modified Hoehn & Yahr Severity of Illness |
7.3; 62.5; 30.2 | — |
| SECONDARY Each Item of UPDRS Part 1 |
2.8; 9.5; 5.0; 4.4 | — |
| SECONDARY Each Item of UPDRS Part 2 (on State) |
4.7; 11.0; 6.0; 7.6; 6.9; 6.6 | — |
| SECONDARY Each Item of UPDRS Part 2 (Off State) |
5.8; 10.5; 6.3; 11.6; 11.6; 9.5 | — |
| SECONDARY Each Item of UPDRS Part 2 (Average of on State and Off State) |
6.7; 13.7; 7.6; 12.1; 11.1; 9.2 | — |
| SECONDARY Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State) |
-10.9; -10.5; -9.4 | — |
| SECONDARY Each Item of UPDRS Part 3 (on State) |
6.3; 5.4; 0.6; 1.6; 1.6; 2.2 | — |
| SECONDARY Each Item of UPDRS Part 4 |
15.1; 5.7; 0.6; 2.5; 3.2; 1.6 | — |
Eligibility Criteria
Inclusion Criteria
- Subject completed the preceding trial 243-08-001.
Exclusion Criteria
- Subject discontinued from the preceding trial 243-08-001.
- Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-08-001.
- Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-08-001.
- Subject had persistent confusion, hallucination, delusion or excitation during trial 243-08-001.
- Subject has abnormal behavior such as obsessive-compulsive disorder and delusion in 243-08-001 study.
- Subject showed serious or extensive application site reactions beyond the application site in the 243-08-001 study.
- Subject has orthostatic hypotension or a systolic blood pressure (SBP) = 30 mmHg at baseline.
- Subject has a history of epilepsy, convulsion etc. during trial 243-08-001.
- Subject develops serious ECG abnormality at the baseline.
- Subject has QTc-interval >= 500 msec at the baseline or subject has an increase of QTc-interval >= 60 msec from the baseline in the trial 243-08-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
- Subject had a serum potassium level = 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ? 100 IU/L) at the end of the period in trial 243-08-001.
- Subject had BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-08-001.
- Subject who plans pregnancy during the trial.
- Subject is unable to give consent.
- Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.
Data sourced from ClinicalTrials.gov (NCT01631825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.